The primary analysis will compare all patients allocated to dexamethasone versus those allocated to placebo, on an “intention-to-treat” basis. A descriptive analysis of the baseline variables will be made for each treatment group, followed by a comparison between both groups.

In the secondary analysis a logistic regression model will be built to estimate the effect of dexamethasone and placebo on the patient's functional status measured with the GOSE at one month and at 6 months. The scale will be dichotomized in unfavorable outcome (GOSE 1–6) and favorable outcome (GOSE 7–8). In this analysis the primary outcome will be adjusted by age, pupil reactivity, blood pressure and GCS. To choose a model, the adequacy and goodness of fit will be measured.

Since the severity of the initial injury will significantly determine the final outcome of the patient, regardless of any treatment, the results of this study will be analyzed using the “sliding dichotomy”. According to this analysis, patients with a less severe initial injury should have a better recovery than those with a severe initial injury. For example, a moderate disability in a patient for whom no more than death or severe disability could be expected is considered a good outcome, and vice versa, consider a moderate disability in a patient with excellent initial prognosis as poor outcome. Patients with a severe initial injury (GCS score of 4 to 5 or, or with a GCS motor score of 2 to 3) will be considered to have a favorable outcome if the 6-month GOS-E score is 3 or higher. Patients with a moderate-to-severe initial injury (GCS score of 6 to 8 or, GCS motor score of 4 to 5) will be considered to have a favorable outcome if the 6-month GOS-E score is 5 or higher, and those with a less initial injury (GCS score of 9 to 12, GCS motor score of 6) will be considered to have a favorable outcome if the 6-month GOS-E score is 7 or higher.

The purpose of the sliding dichotomy approach is to increase the sensitivity (to lower the false negative rate) of the analysis. All these variables will also be analyzed in a pre-specified subgroup analysis comparing patients with a pericontusional edema volume of more than 10 ml in the pre-inclusion CT scan in the study with those who have less than 10 ml of edema volume in the same CT study.

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